H-1B Visa Quality Assurance Analyst Jobs
Quality Assurance Analyst roles qualify for H-1B visa sponsorship as specialty occupations requiring at least a bachelor's degree in computer science, information systems, or a related field. Employers file the LCA with DOL before your I-129 petition, and most QA roles fall under SOC code 15-1253, which shapes prevailing wage calculations and petition strength.
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Get Access To All JobsINTRODUCTION
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
- Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
- Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
- Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
- Review and assess changes for potential impact to product quality and compliance.
- Support and oversee CAPA, change control, validation, and other Quality System activities.
- Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
- Provide Quality support for New Product Introduction (NPI) and complex projects.
- Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
- Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
- Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
- Participate in and lead continuous improvement initiatives and quality projects.
- Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
- Work independently while effectively leading, influencing, and collaborating with cross-functional teams.
BASIC QUALIFICATIONS
- Bachelor's degree in Science or Engineering
- Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
- Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
- Experience with batch record review and manufacturing documentation.
- Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
- Knowledge of computer systems validation / computer systems quality assurance is highly desirable.
- Strong analytical, problem-solving, organizational, and project management skills.
- Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
- Strong English and Spanish written and verbal communication skills.
- Proficiency with word processing, presentation, database, and spreadsheet applications.
- Ability to evaluate compliance issues and interpret quality data/trends.
- Ability to work independently and interact effectively with employees and leadership at all organizational levels.
- Non-Standard Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
INTRODUCTION
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
- Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
- Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
- Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
- Review and assess changes for potential impact to product quality and compliance.
- Support and oversee CAPA, change control, validation, and other Quality System activities.
- Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
- Provide Quality support for New Product Introduction (NPI) and complex projects.
- Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
- Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
- Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
- Participate in and lead continuous improvement initiatives and quality projects.
- Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
- Work independently while effectively leading, influencing, and collaborating with cross-functional teams.
BASIC QUALIFICATIONS
- Bachelor's degree in Science or Engineering
- Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
- Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
- Experience with batch record review and manufacturing documentation.
- Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
- Knowledge of computer systems validation / computer systems quality assurance is highly desirable.
- Strong analytical, problem-solving, organizational, and project management skills.
- Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
- Strong English and Spanish written and verbal communication skills.
- Proficiency with word processing, presentation, database, and spreadsheet applications.
- Ability to evaluate compliance issues and interpret quality data/trends.
- Ability to work independently and interact effectively with employees and leadership at all organizational levels.
- Non-Standard Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
See all 1,088+ H-1B Visa Quality Assurance Analyst Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Assurance Analyst
Verify your SOC code before applying
QA Analyst roles can be classified under multiple SOC codes, and the wrong one weakens your petition. Pull the O*NET profile for 15-1253 to confirm your job duties align before your employer files the LCA.
Target employers with active LCA filing history
Use Migrate Mate to filter QA Analyst roles by employers who have filed LCAs for this occupation, so you're applying to companies that have already cleared the DOL prevailing-wage certification step, not ones figuring it out for the first time.
Gather degree equivalency documents early
USCIS requires a credential evaluation if your QA degree is from outside the U.S. Get a course-by-course evaluation from a NACES-member evaluator before you receive an offer, since delays here can push back your I-129 filing window.
Ask employers about their E-Verify enrollment status
STEM OPT and cap-gap extensions require E-Verify enrollment from your employer. Confirm this before accepting an offer if you're transitioning from OPT, since QA roles at non-enrolled employers can't use the STEM extension bridge.
Negotiate your start date around USCIS processing timelines
H-1B petitions filed in April have an October 1 start date for cap-subject cases. Build this into your offer negotiation so your employer doesn't expect you to start before your status is effective.
Confirm your salary meets the LCA wage level for your metro
DOL assigns wage levels I through IV based on experience and supervision. Run the OFLC Wage Search for SOC code 15-1253 in your target metro before accepting an offer to confirm your salary covers at least Level I prevailing wage.
H-1B Visa Quality Assurance Analyst: Frequently Asked Questions
Does a Quality Assurance Analyst role qualify as a specialty occupation for H-1B purposes?
Yes, provided the position requires at least a bachelor's degree in a directly related field such as computer science, information systems, or engineering. Generic QA roles that accept any degree can face USCIS scrutiny on specialty occupation grounds. Your employer's job description should specify the required degree field, not just list it as preferred, to strengthen the petition.
Which SOC code does a Quality Assurance Analyst typically use for the H-1B LCA?
Most QA Analyst roles are filed under SOC code 15-1253, Software Quality Assurance Analysts and Testers. Some employers use 15-1299 or a business operations code if the role leans toward process auditing rather than software testing. The SOC code your employer selects determines the DOL prevailing wage your offered salary must meet, so confirming the right classification before the LCA is filed matters.
How do I find employers who regularly sponsor H-1B visas for QA Analyst positions?
Migrate Mate filters job listings by employers with verified H-1B LCA filing history for QA and software testing roles, so you can focus your applications on companies that have already navigated the DOL certification process for this occupation. This is more reliable than assuming any tech employer will sponsor, since some only sponsor for senior or engineering-specific roles.
Can my employer file an H-1B petition for a fully remote QA Analyst role?
Yes, but the LCA must list every location where you'll perform work. If you work from home, your home address is a worksite and the DOL prevailing wage for that metro applies, not your employer's office location. If your home metro has a higher prevailing wage, your offered salary must meet that higher threshold or your employer must update the LCA before you begin working remotely.
What happens to my H-1B status if my QA Analyst job is eliminated or my employment ends?
You have a 60-day grace period from your last day of employment to find a new H-1B-sponsoring employer, change to another valid status, or depart the U.S. Your new employer must file an H-1B transfer petition before the grace period expires. USCIS does not extend this window, so starting your job search and transferring quickly is critical.